Tildrakizumab

Generic Name: Tildrakizumab

Brand Names: Ilumya, Ilumetri

Drug Type: Biotech

CAS Number: 1326244-10-3

Unique Ingredient Identifier: DEW6X41BEK

Background: Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis .

The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter .

A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .

Indication: Moderate-severe plaque psoriasis , .

Associated Conditions: Moderate to Severe Plaque Psoriasis

Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.

Phase 3

Recruiting

Conditions: Moderate to Severe Genital Psoriasis

Interventions: Drug: Tildrakizumab 100 mg
Drug: Placebo

First Posted Date: 2024-09-24

Last Posted Date: 2025-05-20

Lead Sponsor: Sun Pharmaceutical Industries Limited

Target Recruit Count: 192

Registration Number: NCT06611163

Locations: 🇺🇸
Medical Dermatology Specialists, Phoenix, Arizona, United States
🇺🇸
Smary Cures Clinical Research, Anaheim, California, United States
🇺🇸
California Dermatology & Clinical Research Institute, Encinitas, California, United States

and more 69 locations

A Study to Assess Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Tildrakizumab

First Posted Date: 2024-07-05

Last Posted Date: 2024-07-05

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 50

Registration Number: NCT06488170

Locations: 🇨🇿
University Hospital Ostrava, Ostrava, Czechia
🇨🇿
Fakultní nemocnice Plzeň, with its registred seat at Edvarda Beneše, Pilsen, Czechia
🇨🇿
University Hospital in Motol, Praha, Czechia

and more 1 locations

A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)

Recruiting

Conditions: Genital Psoriasis

Interventions: Drug: Tildrakizumab

First Posted Date: 2023-09-08

Last Posted Date: 2025-01-29

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 110

Registration Number: NCT06029257

Locations: 🇦🇹
Medizinische Universität Graz, Graz, Styria, Austria

A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Tildrakizumab

First Posted Date: 2023-09-08

Last Posted Date: 2025-01-29

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 50

Registration Number: NCT06030076

Locations: 🇦🇹
Gesundheitszentrum Citypark Graz, Graz, Styria, Austria

Psoriatic Immune Response to Tildrakizumab

Phase 4

Recruiting

Conditions: Psoriasis Vulgaris

Interventions: Drug: Tildrakizumab Prefilled Syringe

First Posted Date: 2022-05-25

Last Posted Date: 2023-08-29

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 10

Registration Number: NCT05390515

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

A Phase Ⅲ Study to Evaluate Tildrakizumab in the Treatment of Chinese Subjects With Moderate to Severe Plaquetype Psoriasis

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Tildrakizumab 100 mg
Drug: Placebo

First Posted Date: 2021-11-05

Last Posted Date: 2023-04-12

Lead Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Target Recruit Count: 220

Registration Number: NCT05108766

Locations: 🇨🇳
The First Affiliated Hospital of Air Force Medical University of PLA, Xi'an, China

Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo

Early Phase 1

Completed

Conditions: Skin and Connective Tissue Diseases
Hypopigmentation
Pigmentation Disorder
Biologic
Skin Diseases
Vitiligo

Interventions: Drug: Tildrakizumab

First Posted Date: 2021-07-21

Last Posted Date: 2024-11-12

Lead Sponsor: Premier Specialists, Australia

Target Recruit Count: 12

Registration Number: NCT04971200

Locations: 🇦🇺
Premier Specialists Pty Ltd, Sydney, New South Wales, Australia

Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Tildrakizumab

First Posted Date: 2021-03-30

Last Posted Date: 2025-05-11

Lead Sponsor: Almirall, S.A.

Target Recruit Count: 782

Registration Number: NCT04823247

Locations: 🇩🇪
Haut- und Laserzentrum Freising, Freising, Bavaria, Germany

The Effects of Tildrakizumab in Treatment of Bullous Pemphigoid

Early Phase 1

Conditions: Pemphigoid, Bullous

Interventions: Drug: Tildrakizumab Prefilled Syringe

First Posted Date: 2020-07-10

Last Posted Date: 2020-07-10

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 16

Registration Number: NCT04465292

Abiraterone Acetate in Combination With Tildrakizumab

Phase 1

Terminated

Conditions: Metastatic Castration Resistant Prostate Cancer

Interventions: Drug: Abiraterone Acetate
Drug: Tildrakizumab

First Posted Date: 2020-07-07

Last Posted Date: 2024-04-25

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 13

Registration Number: NCT04458311

Locations: 🇬🇧
Belfast City Hospital, Belfast, UK, United Kingdom
🇬🇧
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
🇬🇧
The Royal Marsden Hospital Foundation Trust, Sutton, UK, United Kingdom

and more 3 locations

Drug Development Updates

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